FDA Concludes Safety Review of Benicar Heart Risks

June 25, 2014 — In an ongoing safety review of the cardiovascular side effects of Benicar (olmesartan), the U.S. Food and Drug Administration (FDA) has concluded that there is no increased risk.

However, they will update the Prescribing Information to include information from studies linking high-dose Benicar in diabetic patients with higher rates of deadly cardiovascular events, such as heart attack or stroke.

The ROADMAP clinical trial compared Benicar (40-mg/day) to a placebo in patients with type-2 diabetes and at least one other risk-factor for cardiovascular disease. Researchers hoped that Benicar would delay microalbuminuria. Instead, Benicar was associated with five-times as many deaths (15 in the Benicar group compared to 3 in the placebo group), primarily due to heart attacks and sudden cardiac death. Benicar was also associated with an increasing trend of strokes.

The FDA called the results of the ROADMAP trial “unusual and surprising” because drugs that reduce blood pressure are supposed to have beneficial cardiovascular effects.

Benicar was also linked to an increased risk of death in a massive observational study of Medicare patients 65 years or older. Researchers found that patients with diabetes who took 40-mg/day of Benicar were twice as likely to die compared to similar patients who took other ARBs. However, the study also found an increase in survival for non-diabetic patients taking Benicar, which “is not a plausible finding” and raises concerns about credibility.

The FDA concluded that even if high doses of Benicar raise the risk of deadly cardiovascular events for diabetics, the agency believes the benefits of treating high blood pressure outweigh the potential side effects.

The Prescribing Information for Benicar was updated with new information, including the following warning:

“Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.”

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